Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc., NDC: 0143-9246-01.
FDA recall notice · announced September 2, 2020 · Hikma Pharmaceuticals
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc., NDC: 0143-9246-01.
Reason for recall
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Notes
Distribution: Nationwide in the U.S.
Lot/code information: Lot #s: 2005023.1, 2005024.1, 2005025.1, Exp 02/28/2021
Quantity: 97,890 vials
Status: Terminated
Products in this recall event:
- Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatont (D-1533-2020)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.